FOCUS GROUPS WILL EXAMINE DTC ADVERTISING, PHYSICIAN LABELING
The Center for Drug Evaluation and Research (CDER) plans to conduct focus group
studies on a number of topics in 2006, including direct-to-consumer (DTC) advertising
and physician labeling.
The agency typically uses focus groups to help it develop policy initiatives,
according to a Federal Register notice.
CDER didn't reveal the exact nature of the focus groups, but the FDA has been
examining both issues in recent months. The agency acknowledged earlier this
month that it is considering new rules for DTC advertising to ensure that promotions
contain balanced messages. The FDA is also drafting a final physician labeling
rule that would create a standardized labeling format and require risk information
to be placed more prominently on drug labels.
Overall, CDER intends to conduct 20 focus group studies annually, with approximately
10 focus groups and 200 focus group sessions per study, the FDA said. Other
planned topics for focus groups include medication guides, OTC drug labeling
and risk communication.
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